QC: Quality Control
Analytical support for lab and production ranges from the release of raw materials to in-process control. This includes the development of chromatographic methods as well as structural determination of impurities and by-products for release testing.
Activities and Responsibilities:
Development and approval of specifications;
Sampling, analytical check and release of raw materials, intermediates and cleaning samples;
Sampling, analytical check and approval of APIs and finished products;
Release of APIs and final products;
Qualification and maintenance of equipment;
Method transfer and validation;
Approval of documents: e.g. analytical procedures, SOPs;
Stability tests; |